‘Ensuring Safety, Quality of Pharmaceuticals’

KFDA strives to give Korean pharmaceutical firms a leg-up in a bid to enter the U.S. generic drug market

The following are excerpts of an interview between NewsWorld and Jang Byung-won, director general of the Pharmaceutical Safety Bureau at the Korea Food & Drug Administration (KFDA), who spoke about policies to ensure the safety and quality of pharmaceuticals and develop the Korean pharmaceuticals industry.
Question: Will you introduce your bureau to our readers?
Answer: The Pharmaceutical Safety Bureau has a 128-member staff. We are charged with making laws and systems related to the safety management of pharmaceuticals and narcotics, permits for new drugs and general pharmaceuticals, and examinations and quality management of pharmaceuticals, their side-effects and follow-up management.
Of late, the pharmaceutical field is faced with external and internal opportunities and challenges, including the development of life sciences and the fierce competition of general drug markets and the expansion of multinational pharmaceutical firms’ direct market entry. Now is an essential time for ensuring safety management from the scientific and specialization perspectives in a way that customers and patients can feel comfortable as new and dangerous things continue to emerge.
Q: Will you explain strategies to strengthen public confidence regarding the safety of medicines?
A: One of the KFDA’s missions is to make the general public believe in the safety of medicines and their use of them. We’re exerting efforts to provide information about the right use of medicines to consumers, who are the most important clients of policies.
The KFDA plans to expand to 2,000 the number of medical substances subject to drug utilization review and the provision of information about drugs contraindicated in simultaneous use and appropriate age limits by 2010. We’re seeking to establish the tentatively-named Korea Drug Utilization Review Board designed to compile, analyze and review information about the safety of medicines. We plan to introduce, produce and distribute explanations on the use of medicines that customers can get to know well as well as manuals on the safe use of over-the-counter medicines customers can figure out easily. A project to provide information about the use of medicines directly to customers via websites or smart phone applications is also being contemplated.
Q: What steps are in place to beef up the quality of medicines?
A: Advanced countries including the United States and European nations certify and manage the effectiveness and safety of drugs according to their own Good Manufacturing Practice (GMP) standards. Effective this past January, all categories of medicines are obliged to meet drug GMP standards so as to raise the quality of domestically manufactured drugs to global standards. Learning a lesson stemming from the 2009 discovery of asbestos in talc, Korea Pharmacopedia and medicine safety standards have been upgraded in comparison to the standards of advanced countries.
In a bid to advance the quality management of Korean pharmaceutical firms and step up the competitiveness of locally manufactured drugs, the KFDA has conducted an educational program inviting GMP inspectors from advanced countries and introduced a prior mock inspection for exporting candidates in 2010. We’re seeking to join the Pharmaceutical Inspection Cooperation Scheme (PIC/S) in 2012 for mutually recognizing each other’s GMP standards.
Q: Will you elaborate on steps to strengthen the management of narcotics?
A: Recently, overuse or misuse cases of narcotics are not only on a constant rise, but the emergence of new hallucinogenic substances that have not been put on the list of narcotics have posed social problems, raising the need for controlling the possible overuse or misuse of drugs. Overuse or misuse of Propofol, a general anesthetic blamed for the death of Michael Jackson, has come to a head.
The KFDA is seeking to introduce a system in which the KFDA administrator would be allowed to temporarily put on a list of narcotics new discoveries of hallucinogenic substances at the request of law-enforcement authorities in a state of emergency for ensuring public health. We’re considering putting the likes of Propofol and Sibutramine, an agent for treating obesity, on a list of narcotics and drugs that need to be controlled for possible overuse or misuse and taking other steps to strengthen their management systems. We plan to submit a proposal to revise related regulations on producing and keeping a management list of narcotics and drugs that need to be controlled for possible overuse or misuse as well as making frequent reporting on prescriptions and uses obligatory.
Q: What steps are being implemented to step up surveillance over illegally manufactured medicines?
A: One of the KFDA’s functions to ensure a supply of medicines considered safe to customers and patients is to scrutinize the distribution of illegally produced or substandard drugs. There is a need for establishing a comprehensive management system against illegally produced drugs and imports since illegally doctored medicines are increasing on the market via the internet.
The KFDA is conducting special inspections into those who smuggle illegally doctored or substandard drugs into the nation in large quantities in cooperation with customs and police authorities. The frequency of joint surveillance operations against distribution firms in cooperation with local governments will be expanded to five, and intensive and temporary checks-up will be reinforced against distribution firms put on a voluntary self-inspection regime. Websites dealing in illegally produced drugs via the internet and e-mail will be shut down in accordance with MOUs the KFDA has signed with the Korea Internet Association and 12 portal sites.
In the first half of 2010, an online system for retrieving pharmaceuticals has been built in cooperation with the Health Insurance & Assessment Service and other related agencies so that the real-time recovery of illegal and substandard drugs can be managed. Inspections into foreign manufacturers lacking quality management are being made to secure the quality of imported drugs.
Since there is a limit in manpower reacting against the supply of illegal pharmaceuticals, we plan to conduct publicity activities against overuse or misuse of drugs by providing information via diverse channels.
Q: Will you tell us about ways of promoting international cooperation in the pharmaceutical field?
A: The Korean government has discussed mutual recognition in the pharmaceutical GMP area during negotiations of the Korea-U.S. Free Trade Agreement and the Korea-EU Free Trade Agreement. The KFDA has been promoting international cooperation in this area by seeking a plan to accommodate the APEC (Asia-Pacific Economic Cooperation) Harmonization Center in Korea, holding ranking officials’ meetings between Korea and China and between Korea and Singapore as well as Korea-China-Japan director-general meetings on joint studies. We plan to proactively and aggressively tackle issues of international cooperation by forming a team supporting the smooth pursuit of international cooperation.
Q: I understand that there are many foreign original medicines produced by Korean pharmaceutical firms under license whose patents are set to expire?
A: There are a few foreign medicines whose patents are set to expire between 2012 and 2015. If so, Korean pharmaceutical firms will be able to produce the same medicines as the original ones after undergoing equivalency tests. Korea has so far relied on the production of such medicines, but badly needs to develop new medicines. For Korea, creating new products seems extremely hard to realize. It takes approximately 10 to 15 years to develop a new medicine, and the odds for success is estimated at one in 5,000. In the United States, developing a new pharmaceutical product will cost about 2 trillion won to 3 trillion won, whereas the cost for doing so in Korea requires 1 trillion won, too exorbitant a cost to be borne by any of the Korean pharmaceutical firms. In addition, the reality is that the global pharmaceutical industry has virtually almost no new medicines, and Korea is also turning its eyes toward genetic modifications and stem cells.
Q: Does not only a pharmaceutical firm but also a nation has high hops in a success in the development of new medicines?
A: The Korean pharmaceutical industry owns a meager 1.75 percent share in the global market, compared to 35 percent for the United States and 10 percent for Japan. Dong-A Pharmaceutical Co. has posted about 800 billion won in annual sales, equivalent to one-80th of Pfizer, the world’s No. 1 player. Taketa Pharmaceutical Co. of Japan rakes in some 17 trillion won to 18 trillion won in annual turnover, equivalent to the aggregate amounts of the whole of the Korean pharmaceutical industry. The gap in R&D outlays on the development of new drugs is too wide, as Pfizer has set aside 15 percent of its total sales to this end, whereas Korean counterparts have ploughed 5 percent to 7 percent of their sales, giving them less room to spend on new drug R&D outlays.
But Korea is outstanding in terms of generic drug manufacturing facilities and manpower. I bet that the nation has disadvantages in creating new drugs, but it will take a lead in manufacturing generic products, so it is necessary to strive to make the most of the reality of the Korean pharmaceutical industry.
Q: What about Korean pharmaceutical firms’ exporting generic drugs?
A: The generic drug market is saturated since many pharmaceutical firms are competing for a bigger share by releasing products with identical efficacy. One of the solutions Korean firms find is to explore markets in China and Central and South America. The second one is to find their way through the U.S. market. No Korean-made generic drugs have been registered with the U.S. Food and Drug Administration because obtaining permission on medicines from U.S. authorities is a difficult task. All government agencies will have to make concerted efforts in making preparations for Korea’s entry into the U.S. market, including permission and marketing, in order to translate into action a pilot plan to export five Korean-made generic drugs within two or three years. The most important thing we can do is to publicize the prominence of Korean-made generic drugs. The KFDA head office is devoting itself to exploring the U.S. market.
Q: Will you explain the current status and future plans of Korean pharmaceutical firms?
A: Dong-A Pharmaceutical, LG Life Sciences, Yuhan Corp., SK Pharma Co., Daewoong Pharmaceutical Co., Green Cross, Hanmi Pharmaceutical Co. and Dong Hwa Pharm are working hard toward their own goals. In particular, Hanmi is the most active by announcing a grandiose plan, dubbed the “2020 Plan” last year. The plan calls for developing 20 new drugs and joining the ranks of the top 20 pharmaceutical firms in the world by 2020. I do not foresee the plan to be impossible. If the company succeeds in developing two or three new drugs, it would rake in trillions of won in sales, which would be more likely to lead to the development of additional new drugs.
Q: What’re the benefits and purpose of the development of the Korean pharmaceutical industry?
A: The most important thing is to improve public health. First, pharmaceutical firms have to work toward this goal. Second, several parties will have to collaborate in the development of new drugs, which will lead to further strides in the life science industry. Third, the development of new drugs will bring about enormous added value. The KFDA’s most import goal is to ensure the safety of medicines and a supply of prominent pharmaceuticals. Despite budgetary constraints, all KFDA staff members are making flat-out efforts toward that goal in cooperation with the Ministry of Health & Welfare and the Ministry of Knowledge Economy. nw

Jang Byung-won, director general of the Pharmaceutical Safety Bureau at the Korea Food & Drug Administration (KFDA)